E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Primary hypercholesterolemia |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020604 |
E.1.2 | Term | Hypercholesterolemia |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
In patients with primary hypercholesterolemia treated for 4 weeks, To evaluate the efficacy of MK-6213 160 mg co-administered with atorvastatin 20 mg compared to atorvastatin 20 mg monotherapy in lowering LDL-C.
|
|
E.2.2 | Secondary objectives of the trial |
1) To evaluate the safety and tolerability of MK-6213 160 mg treatment. 2) To evaluate the efficacy of MK-6213 160 mg monotherapy compared to placebo in lowering LDL-C, non-HDL-C, Apo B, TC and TG and raising HDL-C. 3) To evaluate the efficacy of MK-6213 160 mg co-administered with atorvastatin 20 mg compared to atorvastatin 20 mg monotherapy in lowering non-HDL-C, Apo B, TC and TG and raising HDL-C
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patient is male or female and 18 to 75 years of age on day of signing informed consent. 2. A female patient who is not of reproductive potential without requiring the use of contraception. A female patient who is not of reproductive potential is defined as: one who has either 1) reached naturalmenopause (defined as 6 months of spontaneous amenorrhea with serum FSH levels in the postmenopausal range as determined bythe laboratory, or 12 months of spontaneous amenorrhea), 2) 6 weeks post surgical bilateral oophorectomywith or without hysterectomy, or 3) bilateral tubal ligation. 3. A female of reproductive potential who agrees to take acceptable contraceptive precautions for the duration of the study. Examples of acceptable contraception may include: • abstinence • use of 2 methods of birth control for the duration of the study including intrauterine device (IUD), diaphragm with spermicide, cervical cap, vaginal sponge, condom • vasectomy (male partner) • exclusive homosexual relationship Note: A successful vasectomyis defined as: (a) microscopic documentation of azoospermia, or (b) greater than 2 yearsago with no resultant pregnancydespite sexual activitypost vasectomy 4. Patient is classified as “low risk” (0-1 risk factors) according to NCEP/ATPIII cardiovascular risk categories and Framingham risk score with an off-treatment LDL-C value of 100-190 mg/dL (2.6–4.9 mmol/L) -or- 5. Patient is classified as “moderate risk” (2 or more risk factors and 10 year CHD risk<10%) according to NCEP/ATPIII cardiovascular risk categories and Framingham risk score with an off-treatment LDL-C value of 100-160 mg/dL (2.6–4.1 mmol/L) -or- 6. Patient is classified as “moderate-high risk” (10-yr CHD risk 10-20%) according to NCEP/ATPIII cardiovascular risk categories and Framingham risk score with • an off-treatment LDL-C value of 100-145 mg/dL (2.6–3.6 mmol/L) • or, off-treatment LDL-C 100-130 mg/dL (2.6–3.4 mmol/L) if patient was taking lipid therapy more potent than atorvastatin 10 mg at the time of screening (See Appendix 6.3) 7. Diabetic patients NOTtaking lipid-lowering medication, with LDL-C 100-130 mg/dL (2.6–3.4 mmol/L),with<2 other cardiovascular risk factors, and without microalbuminuria who meet all other entrycriteria are eligible (see Section 2.3 Patient Exclusion Criteria (h). |
|
E.4 | Principal exclusion criteria |
Patient has a history of secondary hypertension (high blood pressure), cardiovascular (heart), renal (kidney), neurologic (nervous system), respiratory (lung), hepatic (liver) or metabolic disease. Patient has a history of mental instability or drug/alcohol abuse within the past 5 years. Patient drinks more than 2 alcoholic drinks per day. Patient is pregnant or nursing. Patient is HIV positive. Patient has a history of cancer within the past 5 years. Patient has been in a investigational trial within the last 30 days |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Reduction in LDL-Cholesterol |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 19 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 14 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 14 |